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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System.

The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™M ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.

The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

Modifications have been made to Planning application to include Alliance™ Glenoid implant system as a Pure Planning option (i.e. no Guides and Bone Models). In addition, modifications have been made to the user interface of the overall planning application. The planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.

This FDA 510(k) premarket notification for the Signature™ ONE System does not contain the specific acceptance criteria, detailed study results, and statistical information typically required to fully answer your request regarding device performance and its proof. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study proving the device meets predefined clinical acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) or corresponding reported device performance metrics in a table format for clinical efficacy. The "Device Performance Testing" section mentions "Engineering Analysis" to "ensure the performance of the implemented features and verify related design inputs" but does not provide details on what these performance metrics were or their targets.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify any sample size for a test set for clinical performance evaluation. It mentions "patient-specific radiological images" are used for planning, but no details about a dedicated test set of patients or images for validation are provided. Therefore, data provenance (country of origin, retrospective/prospective) is also not available here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The application is for a planning and guiding system, where the ground truth regarding surgical accuracy would typically be established by comparing the planned outcome to the actual intraoperative or post-operative outcome, often involving expert surgeons. However, no such study details are present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided as there is no described test set of clinical images or cases requiring ground truth adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a planning and guiding system, not an AI diagnostic tool where human reader performance would typically be enhanced.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the Signature™ ONE System as assisting in "pre-operative planning and/or intra-operative guiding of surgical instruments." This inherently implies a human-in-the-loop system (the surgeon). The "planning application" is a software component, but its performance is not described in a standalone, algorithm-only context of clinical efficacy in this document. The "Software Verification and Validation Testing" addresses the software's compliance with regulations like IEC 62304 and its concern level ("moderate"), implying testing of its functionality and reliability, but not its clinical performance as a standalone entity in terms of accuracy against ground truth.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. For a surgical planning and guidance system, ground truth would ideally come from direct measurements of surgical accuracy and alignment post-procedure, or potentially surrogate measures confirmed by expert assessment.

8. The sample size for the training set

This information is not provided. While the system uses "patient-specific radiological images" for planning, the document does not discuss a "training set" in the context of an AI/ML model where a large dataset is used to train an algorithm. The system appears to be based on computational algorithms for planning rather than a deep learning model trained on a vast image dataset.

9. How the ground truth for the training set was established

This information is not provided as there is no discussed training set.

Summary of what is present:

• Software Verification and Validation Testing: This was conducted to satisfy FDA guidance and IEC 62304 for medical device software. The software is classified as "moderate" level of concern.
• Engineering Analysis: Performed to ensure performance of implemented features and verify design inputs.
• Usability Engineering: Addressed user interactions.

In conclusion, this 510(k) notification focuses on the substantial equivalence of the Signature™ ONE System to previously cleared predicate devices, asserting that its modifications (like adding Alliance™ Glenoid system compatibility) do not raise new questions of safety and effectiveness. It provides a general overview of verification and validation activities (software, engineering, usability) but lacks the detailed performance study results and specific acceptance criteria that you requested for a comprehensive understanding of the device's proven clinical effectiveness.

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